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Pharmacy Assurance coordination for Northern Ireland-led studies

Pharmacy Assurance coordinates a standardised single technical pharmacy review for eligible studies across the UK. The completed review can be used by all participating NHS/HSC sites across the UK to support local capacity and capability assessments and study set up in pharmacy departments.


What are the benefits of Pharmacy Assurance?

For Sponsors/Applicants

  • fewer duplicated queries from multiple sites
  • streamlined site set up


For Pharmacy Departments/Participating Sites

  • an assured level of detail thanks to comprehensive and standardised information in the pharmacy review form
  • information at the right time to support capacity and capability assessments
  • reduction in the number of queries during capacity and capability assessments and during study set up


What studies are eligible?

Pharmacy Assurance is an integral part of study set-up in the NHS and HSC. We currently accept all Phase I-III clinical trials of investigational medicinal products (CTIMPs) when:

the trial is taking place at multiple secondary care sites in the HSC/NHS and;

the lead NHS R&D office is in Northern Ireland

It is expected that HSC sponsors in Northern Ireland submit their eligible studies for Pharmacy Assurance. Other non-NHS/non-HSC sponsors are also strongly encouraged to submit for Pharmacy Assurance

Information about applying for Pharmacy Assurance in other Nations is available on the IRAS website.


How does the process work?

Pharmacy Assurance is a pre-submission review, which takes place before e-submission in IRAS. This is to ensure that information is available to sites in a timely manner in order to conduct their capacity and capability (C&C) review. Studies should be submitted for Pharmacy Assurance no later than three weeks prior to submission in IRAS.

For Information on how to apply and to obtain the documentation required, please visit the IRAS website.


What about Radiation Assurance?

Radiation Assurance is a UK-wide process fully managed by the HRA on behalf of all four UK nations for studies which are taking place in NHS/HSC secondary care settings. For more information about applying to the HRA for radiation assurance, please visit the HRA website.



Please email the HSC R&D Approvals Service at if you have any questions about the Pharmacy Assurance process in Northern Ireland.